1. plant design

Combined with the rich experience of the project team, the verification system and GMP system are optimized and improved according to the existing configuration and operation of the enterprise. Durst advocates the introduction of new verification ideas and concepts in Europe and the United States to promote project implementation:

(I) plant design strategy: from the FDA GMP regulations and GMP appendix standard compliance, process flow, capacity planning, production organization, organizational structure and other aspects of plant design, to ensure that the design of the plant can meet the regulatory compliance requirements of the next 10-15 years;

(II) in the design of the plant, the introduction of risk management concept, and combined with the European and American GMP requirements, the plant system design and communication, in accordance with the new ISPE for the technical standards of each verification module requirements, design workshop and layout;

(III) Durst's team will send the drawings to the pharmaceutical company, which can select the appropriate construction party for construction and construction according to the design drawings.

Durst has assisted several pharmaceutical companies with design consulting, including:

Shanghai a radioactive plant design consulting case:

After the Durst DST team arrived at the site, through the analysis and optimization of the enterprise's design scheme, it helped the enterprise to optimize the compliance of the design scheme; and helped the enterprise to solve many design defects; at the same time, it helped the enterprise to save about 1 million operating expenses per year.

Design and Implementation of Guangzhou Zhongtong Biochemical FDA cGMP Project:

Durst DST team designed the overall plant of the enterprise to meet the requirements of FDA cGMP in the United States. Durst designed the production workshop, weighing configuration center and QC laboratory (renovation) of the enterprise according to conceptual design (CD), basic design (BD) and detailed design.

Chengdu Shengnuo Biological FDA cGMP Project Consultation:

The DST team signed an overall design and construction process consultation project with Chengdu Shengnuo Biology. The DST team conducted overall design consultation on the four production lines of the enterprise, helping the enterprise to save 800-10 million yuan in construction costs under the condition of meeting FDA cGMP in the United States.

At the same time, Dust DST team also arranged personnel to the equipment manufacturers to carry out the corresponding FAT assistance, to help enterprises to solve the equipment design risks of a number of injections.

2. engineering management

Engineering management is an important work in the construction of the factory, because the construction unit is usually carried out for many units at the same time, the construction unit for GMP clean plant understanding is often not up to the requirements of the enterprise, and the pharmaceutical company's internal personnel on the construction technology understanding is relatively small. Therefore, the supervision and management of construction is an important measure to ensure the construction of clean workshop on schedule, quality and quantity. Durst has a perfect GEP system in factory design and factory construction management. Durst is in engineering management and strictly in accordance with GEP engineering quality management.

3. GEP Project Construction Management Standard

System construction in strict accordance with GEP project construction management standards,

1. Overall program of project management and project implementation;

2. Project URS (User Requirements Standard);

3. Project investment budget and capital plan;

4. Technical scheme for project construction;

5. Master plan for project validation;

6. Establishment of project document system and document management control;

7. Project equipment control, including the whole process control from equipment selection, procurement to installation confirmation;

8. Project installation confirmation documents;

9. Project construction management work procedures and process control work standards.

Construction Process Management of 4. GEP Project

Durst arranges project experts to conduct process inspections and audits at the customer site to ensure that the site meets requirements. Due to the construction process, there are many risk projects for the later plant maintenance, clean environment to meet the requirements are very important. In particular, the control of some mold contamination requires audits and inspections during the design and construction phases.

Experienced experts in Durst Engineering helped enterprises avoid the follow-up risks of products and the risks of GMP inspection in Europe and the United States through on-site implementation guidance, which was recognized by customers, equipment manufacturers and engineering construction suppliers, and helped Party A recover many construction losses and rectification losses.

Key node check	Illustration
(1) Confirmation of drawings before construction and on-site confirmation, inspection of exhaust air and chilled water tower, etc., and design the overall air supply and exhaust air based on the rose wind direction diagram (2) Design inspection of plant and weighing center
(3) Material mobilization and on-site pipe fitting processing management
(4) Check the air supply and return air of the workshop during the construction phase to ensure that the concealed works meet the requirements.
(5) Technical mezzanine inspection and audit
(6) Design and construction inspection of process pipeline
(7) Installation inspection of key equipment, training and guidance of on-site construction personnel